MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR) OVATION IX; ILIAC LIMB

Model Number	TV-IL1412140-J
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately 2.5 years post initial procedure, the patient presented emergently with abdominal pain.The physician found that the ovation iliac limb on the patient's left side had pulled out of the iliac artery and was in the aaa with a type ib endoleak present.The physician elected to treat the patient by implanting two (2) additional iliac limb ovation devices on (b)(6) 2019.The patient is reportedly in stable condition and a good seal was achieved post re-intervention.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported left common iliac cranial migration is unconfirmed due to a lack of comparative imaging; however, based on the position of the stent in the aortic sac it is highly probable.The reported type ib endoleak of the left common iliac artery is confirmed.Device, user, procedure or anatomy relatedness of this event could not be determined.The final patient status was reported to be in stable condition following a successful secondary endovascular procedure.The device remains implanted; therefore, a device evaluation cannot be completed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: g1,2: contact office / name: updated, h6: result code: remove code 3233, h6: conclusion code: remove code 11.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8823634
• Report Number: 3008011247-2019-00118
• Device Sequence Number: 2348696
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412140J1
• UDI-Public: +M701TVIL1412140J1/$$3160819FS06101525P
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2018
• Device Model Number: TV-IL1412140-J
• Device Catalogue Number: TV-IL1412140-J
• Device Lot Number: FS061015-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB: FS011816-05; OVATION IX MAIN BODY: FS030316-43; OVATION IX ILIAC LIMB: FS011816-05; OVATION IX MAIN BODY: FS030316-43
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR